Generic name: Acetaminophen, Diphenhydramine, Pseudoephedrine
Kenvue Brands LLC
Dosage Form
N/A
Manufacturer
Kenvue Brands LLC
This medication contains important usage instructions, warnings, and side effect information that you should review before use.
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ nasal congestion ■ sinus congestion and pressure
■ helps clear nasal passages
■ promotes nasal and sinus drainage
■ temporarily reduces fever
When using this product do not exceed recommended dose
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains ■ headache ■ sore throat
■ nasal congestion ■ sinus congestion and pressure
■ sneezing and runny nose
■ helps clear nasal passages ■ temporarily reduces fever
When using this product
■ do not exceed recommended dose
■ excitability may occur, especially in children
■ marked drowsiness may occur
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ avoid alcoholic drinks
■ be careful when driving a motor vehicle or operating machinery
| adults and children 12 years and over | ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor |
| children under 12 years | ask a doctor |
Keep out of reach of children.
■ nervousness, dizziness, or sleeplessness occur
■ pain or nasal congestion gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present
■ new symptoms occur
These could be signs of a serious condition.
taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are
■ taking the blood thinning drug warfarin
■ taking sedatives or tranquilizers
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ with any other product containing diphenhydramine, even one used on skin
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
■ if you have ever had an allergic reaction to this product or any of its ingredients
■ store between 20 - 25°C (68 - 77°F)
■
do not use if blister unit is torn or broken
NEW
NDC 50580-660-16
SUDAFED
SINUS
CONGESTION + COLD SEVERE
Acetaminophen,
Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Nasal Decongestant
DAYTIME
• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES
actual size
Acetaminophen,
Diphenhydramine HCI, Pseudoephedrine HCI,
Pain Reliever/Fever Reducer, Antihistamine,
Nasal Decongestant
NIGHTTIME
• SINUS PRESSURE + CONGESTION
• FEVER
• HEAD + BODY ACHES
• RUNNY NOSE
• SNEEZING
actual size
12 TABLETS; 4 TABLETS; 16 TABLETS TOTAL
[image: img_5383df54-7692-5aa0-e063-6394a90acf49]
Photos of the product and/or packaging supplied by the manufacturer.
SUDAFED® SINUS CONGESTION + COLD SEVERE DAY
Drug Facts
This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
■ if you have ever had an allergic reaction to this product or any of its ingredients
■ liver disease
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ trouble urinating due to an enlarged prostate gland
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention
is critical for adults as well as for children even if you do not notice any signs or symptoms.
EXTRA STRENGTH TYLENOL® SEVERE COUGH + SORE THROAT NIGHT
Drug Facts
This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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